Cesarean DeliveryNCT00799955
Comparing 2 Types of Pain Relief After Cesarean Delivery: Spinal Morphine and TAP Block
A study testing Ultrasound-guided TAP block in people with Cesarean Delivery, run by University of British Columbia at 1 site in Canada.
Trial summary
Summary Brief Summary Standard care for pain relief after cesarean delivery is spinal morphine. Spinal morphine may be unsuitable for patients having general anesthetic or prior morphine-related side effects and can be less effective in patients with morphine tolerance. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- Ultrasound-guided TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective cesarean delivery under spinal anesthesia patients.
- >28 weeks gestation
- ASA 1 and 2 classification of health
- Mothers presenting to the assessment unit with ruptured membranes or in early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery.
- Able to read and understand English,
- Only patients expected to deliver before midday will be approached for participation in the trial to facilitate post-operative data collection.
Who cannot join
- Mothers in active labour
- ASA classification 3 or above
- Emergency cesarean delivery for fetal heart rate abnormalities
- Cesarean delivery under general anesthesia
- Maternal age <19
- BMI >40.
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- Cesarean deliveries where a CSE is planned.
- Mothers with a history of drug allergy to morphine or to local anesthetics
- Mothers who are likely to deviate from standard postpartum analgesia protocol because of history of morphine tolerance or sensitivity.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Women's Hospital Dept of Anesthesia
Vancouver, British Columbia, V6H 3N1
About this study
Official title: Comparison of Efficacy and Side Effects of Intrathecal Morphine and TAP Block for Post-cesarean Analgesia
Summary Brief Summary Standard care for pain relief after cesarean delivery is spinal morphine. Spinal morphine may be unsuitable for patients having general anesthetic or prior morphine-related side effects and can be less effective in patients with morphine tolerance. An alternative is a TAP block where local anesthetic is deposited between the abdominal muscles consequently numbing the area and providing pain relief. The investigators believe a TAP block will provide equivalent pain relief to spinal morphine.
Read the detailed description
Detailed Description In North America, the standard of care is neuraxial morphine. This is an effective analgesic, but can still cause problems with nausea, vomiting and itching. Spinal morphine may be unsuitable for patients who have had morphine-related side effects in the past and can be less effective in patients with morphine tolerance. It is also poorly suited for patients who have had a general anesthetic, as anesthesiologists do not routinely access the spinal space purely for analgesia. It is only when they are using the spinal route for surgical anesthesia, that they will also deposit morphine to provide pain relief after surgery.
The abdominal wall incision is an important contributor to pain following a cesarean delivery. The nerves supplying the anterior abdominal wall between the internal oblique and transversus abdominis muscles. By depositing local anesthetic solution between these muscles on each side, it is possible to block all these nerves and provide analgesia for the incision of the anterior abdominal wall. This is known as the transversus abdominis plane block or TAP block.
Studies have shown the TAP block to be useful for midline laparotomies for open prostatectomies, bowel resection and as rescue analgesia for abdominal surgery. There are two studies which look specifically at TAP block after cesarean delivery but none of them have compared it directly the current standard.
This study is a direct comparison of spinal morphine and TAP block. Obviously, adequate analgesia is of paramount importance to the patient and those caring for her. Studies to date indicate that the TAP block provides similar analgesia to spinal morphine in the early post-operative period. Therefore it would be a reasonable alternative for those patients who cannot have spinal morphine or who can not tolerate spinal morphine due to its side effects.
The primary objective will be to investigate whether the tranversus abdominis plane block provides equivalent analgesia post-cesarean delivery, as intrathecal morphine.
The secondary objective will be to determine whether there is a difference in post-operative abdominal scar pain, at three months post-surgery.
This study will be a prospective, randomized, placebo-controlled, double blinded study.
The study will involve two groups. Both groups will have spinal anesthesia for the surgery provided with 9-12 mg heavy bupivacaine and 10 mcg fentanyl.
- Control group: standard care plus a placebo block.
- Intervention group: no additional spinal medications will be given and an ultrasound-guided TAP Block will be given instead of the standard intrathecal morphine.
Standard post-cesarean analgesia and PONV orders will be resumed post-delivery.
- Conditions
- Cesarean Delivery
- Being tested
- Placebo block, Ultrasound-guided TAP block
- Keywords
- Cesarean delivery, post-operative analgesia, TAP block, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo blockProcedure or surgery
100 micrograms of spinal morphine
Ultrasound-guided TAP blockProcedure or surgery
1.5mg/kg of 0. 5% ropivacaine (to maximum dose of 20 mls = 100mg on each side) will be injected into the transversus abdominis plane, on each side
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Subjects will receive 100 micrograms of spinal morphine, at the time of spinal needle insertion (standard care at BCW). At the end of the case, one of two investigators, using ultrasound, will visualize the transversus abdominis plane. A capped needle will be pushed against the skin to mimic the pressure sensation of the TAP block. The needle will not break the skin and nothing will be injected in this control group. The procedure will then be repeated on the other side. A dressing will be applied on each side to blind the subject and researcher to which group she is in. Receives: Procedure: Placebo block |
| 2 | Active comparator | No additional spinal medications will be given. At the end of the case, one of the two investigators, under sterile conditions, and using ultrasound, will visualize the tip of a blunt regional anaesthesia needle entering the transversus abdominis plane. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0. 5% ropivacaine (to maximum dose of 20 mls = 100mg on each side) will be injected, under vision, into the transversus abdominis plane, on each side. The subjects will still have spinal anesthesia of the abdomen and therefore will not feel needle insertion as sharp although most will have a sensation of pressure. A dressing will be applied over the needle's entry points. Receives: Procedure: Ultrasound-guided TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine equivalents used in the 24h post-delivery
Measured: 24 hours post operation
Secondary outcomes (1)
Pain scores at rest, and with movement as assessed by verbal analogue score on arrival to recovery and at 2, 6, 10, and 24h post-spinal drug administration; post-operative nausea and vomiting scores, sedation score, presence or absence of itch; presence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roanne Preston, MD, FRCPC, Principal investigator, University of British ColumbiaHeather Loane, MBBS, B.Med.Sci, Study director, University of British ColumbiaJoanne Douglas, MD, FRCPC, Study director, University of British ColumbiaSimon Massey, MB BCh, MRCP, FRCA, Study director, University of British ColumbiaJessica Tyler, BSc, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799955
- Sponsor's protocol ID
- H08-01726
- Status last verified
- Jan 2013
- First submitted
- 26 Nov 2008
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Side Effects of Intrathecal Morphine and TAP Block for Post-cesarean Analgesia
- ClinicalTrials.gov ID
- NCT00799955
- Acronym / sponsor ID
- H08-01726
- Conditions
- Cesarean Delivery
- Keywords
- Cesarean delivery, post-operative analgesia, TAP block, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Summary Brief Summary Standard care for pain relief after cesarean delivery is spinal morphine. Spinal morphine may be unsuitable for patients having general anesthetic or prior morphine-related side effects and can be less effective in patients with morphine tolerance. An alternative is a TAP block where local anesthetic is deposited between the abdominal muscles consequently numbing the area and providing pain relief. The investigators believe a TAP block will provide equivalent pain relief to spinal morphine.
Detailed description
Detailed Description In North America, the standard of care is neuraxial morphine. This is an effective analgesic, but can still cause problems with nausea, vomiting and itching. Spinal morphine may be unsuitable for patients who have had morphine-related side effects in the past and can be less effective in patients with morphine tolerance. It is also poorly suited for patients who have had a general anesthetic, as anesthesiologists do not routinely access the spinal space purely for analgesia. It is only when they are using the spinal route for surgical anesthesia, that they will also deposit morphine to provide pain relief after surgery.
The abdominal wall incision is an important contributor to pain following a cesarean delivery. The nerves supplying the anterior abdominal wall between the internal oblique and transversus abdominis muscles. By depositing local anesthetic solution between these muscles on each side, it is possible to block all these nerves and provide analgesia for the incision of the anterior abdominal wall. This is known as the transversus abdominis plane block or TAP block.
Studies have shown the TAP block to be useful for midline laparotomies for open prostatectomies, bowel resection and as rescue analgesia for abdominal surgery. There are two studies which look specifically at TAP block after cesarean delivery but none of them have compared it directly the current standard.
This study is a direct comparison of spinal morphine and TAP block. Obviously, adequate analgesia is of paramount importance to the patient and those caring for her. Studies to date indicate that the TAP block provides similar analgesia to spinal morphine in the early post-operative period. Therefore it would be a reasonable alternative for those patients who cannot have spinal morphine or who can not tolerate spinal morphine due to its side effects.
The primary objective will be to investigate whether the tranversus abdominis plane block provides equivalent analgesia post-cesarean delivery, as intrathecal morphine.
The secondary objective will be to determine whether there is a difference in post-operative abdominal scar pain, at three months post-surgery.
This study will be a prospective, randomized, placebo-controlled, double blinded study.
The study will involve two groups. Both groups will have spinal anesthesia for the surgery provided with 9-12 mg heavy bupivacaine and 10 mcg fentanyl.
- Control group: standard care plus a placebo block.
- Intervention group: no additional spinal medications will be given and an ultrasound-guided TAP Block will be given instead of the standard intrathecal morphine.
Standard post-cesarean analgesia and PONV orders will be resumed post-delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: Placebo blockSubjects will receive 100 micrograms of spinal morphine, at the time of spinal needle insertion (standard care at BCW). At the end of the case, one of two investigators, using ultrasound, will visualize the transversus abdominis plane. A capped needle will be pushed against the skin to mimic the pressure sensation of the TAP block. The needle will not break the skin and nothing will be injected in this control group. The procedure will then be repeated on the other side. A dressing will be applied on each side to blind the subject and researcher to which group she is in. |
| 2 | Active comparator | Procedure: Ultrasound-guided TAP blockNo additional spinal medications will be given. At the end of the case, one of the two investigators, under sterile conditions, and using ultrasound, will visualize the tip of a blunt regional anaesthesia needle entering the transversus abdominis plane. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0. 5% ropivacaine (to maximum dose of 20 mls = 100mg on each side) will be injected, under vision, into the transversus abdominis plane, on each side. The subjects will still have spinal anesthesia of the abdomen and therefore will not feel needle insertion as sharp although most will have a sensation of pressure. A dressing will be applied over the needle's entry points. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Elective cesarean delivery under spinal anesthesia patients.
- >28 weeks gestation
- ASA 1 and 2 classification of health
- Mothers presenting to the assessment unit with ruptured membranes or in early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery.
- Able to read and understand English,
Key exclusion criteria (9 listed)
- Mothers in active labour
- ASA classification 3 or above
- Emergency cesarean delivery for fetal heart rate abnormalities
- Cesarean delivery under general anesthesia
- Maternal age <19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo block100 micrograms of spinal morphine | Procedure or surgery | 1 |
| Ultrasound-guided TAP block1.5mg/kg of 0. 5% ropivacaine (to maximum dose of 20 mls = 100mg on each side) will be injected into the transversus abdominis plane, on each side | Procedure or surgery | 2 |
Primary outcome
Morphine equivalents used in the 24h post-delivery
Time frame: 24 hours post operation
1 secondary outcome
Pain scores at rest, and with movement as assessed by verbal analogue score on arrival to recovery and at 2, 6, 10, and 24h post-spinal drug administration; post-operative nausea and vomiting scores, sedation score, presence or absence of itch; presence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roanne Preston, MD, FRCPC principal investigator
University of British Columbia
Heather Loane, MBBS, B.Med.Sci study director
University of British Columbia
Joanne Douglas, MD, FRCPC study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided TAP block in people with Cesarean Delivery, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine equivalents used in the 24h post-delivery (time frame: 24 hours post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.